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Study ID

106750

Study Title

Observer-blind monocentric study in adults aged between 18-60 years to evaluate reactogenicity and immunogenicity of 1 and 2 administrations of pandemic monovalent influenza vaccines administered at different antigen doses and adjuvanted or not

Observer-blind monocentric study in adults aged between 18-60 years to evaluate reactogenicity and immunogenicity of 1 and 2 administrations of pandemic monovalent influenza vaccines administered at different antigen doses and adjuvanted or not

Phase

phase 1

Acronym

Secondary IDs

FDA Regulated Intervention?

Section 801 Clinical Trial

Delayed Posting

IND/IDE Protocol

no

IND/IDE Grantor

IND/IDE Number

IND/IDE Serial Number

Has Expanded Access

no

Study Type

Interventional

Oversight Authority

Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Sponsor

GlaxoSmithKline

Collaborators

Brief Summary

Detailed Description

Record Verification Date

September 28, 2011

Status

Completed

Why Study Stopped

Study Start Date

March 2006

Study Completion Date

Study Completion Date Type

Primary Completion Date

Primary Completion Date Type

Primary Purpose

prevention

Allocation

Randomized

Masking

Single Blind

Masked Subject

no

Masked Caregiver

no

Masked Investigator

no

Masked Assessor

no

Study Design (Assignment)

Parallel Assignment

Study Classification (Endpoint)

Safety/Efficacy Study

Primary Outcomes

To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers.
Time Frame:
Safety Issue: No

To evaluate the safety and reactogenicity of the study vaccines in term of solicited local and general adverse events, unsolicited adverse events and serious adverse events"
Time Frame:
Safety Issue: No

Secondary Outcomes

To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
Time Frame:
Safety Issue: No

To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Time Frame:
Safety Issue: No

Inclusion criteria:• A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. • Healthy subjects as established by medical history and clinical examination before entering into the study.• If the subject is female, she must be of non-childbearing potential.

Exclusion criteria: • Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.• Administration of an influenza vaccine other than the study vaccines during the entire study period.• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination • History of hypersensitivity to vaccines.• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.• Acute disease at the time of enrolment. • Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.• lactating women• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.

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September 17, 2009

September 15, 2014

Protocol ID

106750

Clinical Study ID

106750

Official Study Title

Observer-blind monocentric study in adults aged between 18-60 years to evaluate reactogenicity and immunogenicity of 1 and 2 administrations of pandemic monovalent influenza vaccines administered at different antigen doses and adjuvanted or not